Sec. 2039. ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCIENTIFIC RESEARCH
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## SEC. 2039 ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCIENTIFIC RESEARCH **[**[42 U.S.C. 282 note](/us/usc/t42/s282)**]** ###
(a)Establishment Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall convene a working group under the Advisory Committee to the Director of the National Institutes of Health (referred to in this section as the “Advisory Committee”), appointed under section 222 of the Public Health Service Act (42 U.S.C. 217a), to develop and issue recommendations through the Advisory Committee for a formal policy, which may incorporate or be informed by relevant existing and ongoing activities, to enhance rigor and reproducibility of scientific research funded by the National Institutes of Health. ###
(b)Considerations In developing and issuing recommendations through the Advisory Committee under subsection (a), the working group established under such subsection shall consider, as appropriate— ####
(1)preclinical experiment design, including analysis of sex as a biological variable; ####
(2)clinical experiment design, including— #####
(A)the diversity of populations studied for clinical research, with respect to biological, social, and other determinants of health that contribute to health disparities; #####
(B)the circumstances under which summary information regarding biological, social, and other factors that contribute to health disparities should be reported; and #####
(C)the circumstances under which clinical studies, including clinical trials, should conduct an analysis of the data collected during the study on the basis of biological, social, and other factors that contribute to health disparities; ####
(3)applicable levels of rigor in statistical methods, methodology, and analysis; ####
(4)data and information sharing in accordance with applicable privacy laws and regulations; and ####
(5)any other matter the working group determines relevant. ###
(c)Policies Not later than 18 months after the date of enactment of this Act, the Director of the National Institutes of Health shall consider the recommendations developed by the working group and issued by the Advisory Committee under subsection
(a)and develop or update policies as appropriate. ###
(d)Report Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health shall issue a report to the Secretary of Health and Human Services, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives regarding recommendations developed under subsection
(a)and any subsequent policy changes implemented, to enhance rigor and reproducibility in scientific research funded by the National Institutes of Health. ###
(e)Confidentiality Nothing in this section authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
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